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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025268
Receipt No. R000029047
Scientific Title Analyses of eye movement and motor functions with the improvement of writing skills
Date of disclosure of the study information 2016/12/16
Last modified on 2019/06/17

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Basic information
Public title Analyses of eye movement and motor functions with the improvement of writing skills
Acronym Analyses of eye movement and motor functions with the improvement of writing skills
Scientific Title Analyses of eye movement and motor functions with the improvement of writing skills
Scientific Title:Acronym Analyses of eye movement and motor functions with the improvement of writing skills
Region
Japan

Condition
Condition Typically developing adults
Typically developing students
Classification by specialty
Not applicable Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we first analyze the eye movement patterns and motor functioning during handwriting for typically developing students and adults by using an eye-tracker. We also examine whether copying the segment by sequential stimulus presentation is effective for our participants to improve their writing skills and develop their eye movement patterns and motor functioning.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes - Writing time
- Standard scores of the Beery VMI-6
- Mean number of fixation
- Mean fixation duration
- Percentage of total fixation duration in writing time
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Students are instructed to copy the segments of a sentence that are presented in a temporal sequence. Training will last for about 15 minutes a day, up to a maximum of 4 days, until students are able to fluently copy the sentence in a target time.
Interventions/Control_2 We do not conduct any copying training for typically developing adults.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
11 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria Regardless of the diagnosis of developmental disabilities, all participants should be enrolled in a mainstream elementary school, junior high school, and university.
Key exclusion criteria - Persons who cannot understand and agree on the purpose and method of this study
- Persons whose mother language is not Japanese
- Persons who are difficult to visit our lab for one to five times
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Mikimasa
Middle name
Last name Omori
Organization Showa Women's University
Division name Department of Psychology
Zip code 154-8553
Address 1-7-57, Taishido, Setagaya-ku, Tokyo, 154-8553
TEL 03-3411-5094
Email mikkiomori@swu.ac.jp

Public contact
Name of contact person
1st name Mikimasa
Middle name
Last name Omori
Organization Showa Women's University
Division name Department of Psychology
Zip code 154-8553
Address 1-7-57, Taishido, Setagaya-ku, Tokyo, 154-8553
TEL 03-3411-5094
Homepage URL
Email mikkiomori@swu.ac.jp

Sponsor
Institute Showa Women's University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Show Women's University IRB
Address 1-7-57, Taishido, Setagaya-ku, Tokyo, 154-8553
Tel 0334117351
Email kenkyu@swu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 10 Day
Date of IRB
2016 Year 12 Month 10 Day
Anticipated trial start date
2016 Year 12 Month 16 Day
Last follow-up date
2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 14 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029047

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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